Our prior U.S. Pat. No. 6,432,105B1 describes a novel electrosurgical instrument in particular a bipolar electrosurgical instrument that is configured for use in minimally invasive surgery (MIS) and other electrosurgical procedures. The instrument is constructed with a rigid end as a bipolar electrode comprising spaced rounded electrodes. The electrode preferably comprises spaced hemispherically-shaped electrically conductive members projecting from the end of the housing. When energized, a bipolar discharge is generated between the bare ends of the electrode. To our knowledge, such a configured electrode has not been used nor suggested for use for topical application to the skin of a patient for the non-ablative treatment of periorbital rhytides and midface laxity or in general removal of wrinkles or other cosmetic skin tightening procedures to improve the appearance of skin tissue.
Among the features described in the prior patent is the use of 3.8-4 MHz radio-frequency (RF) energy especially because of its ability to combine cutting and hemostasis during the procedure.
With the emerging trend of aesthetic medical therapy, several modalities have been developed to further the drive for human self-preservation. Cosmetic and oculoplastic surgery have increasingly crossed paths in the pursuit of noninvasive procedures with which to rejuvenate the facial skin. One of the recent innovations in oculofacial surgery involves the use of nonablative laser and light sources to reduce the appearance of facial creases. However, disadvantages of laser-based treatments include the necessity for multiple treatments and results that may regress or have unpredictable results. Moreover, the efficacy of such systems done on cases with severe skin laxity does not appear satisfactory in some patients.
Recent advances in management of flaccid skin disorders have led to the development of radiofrequency treatment. Several devices were developed to deliver radiofrequency energy in a non-ablative fashion. The principle of radio-frequency differs from laser-based methods in that it produces an electric current that generates heat through resistance in the dermis and subcutaneous tissue rather than a selective photothermolysis employed in lasers. Studies by Kushikata et al. “Is topical anesthesia useful in noninvasive skin tightening using radiofrequency?.” J. Dermatologic Surgery 2005; 31: 526-533; and Fitzpatrick R. et al. “Multicenter study of noninvasive radiofrequency for periorbital tissue tightening”. Lasers in Surgery and Medicine 2003; 33:232-242; and Fritz M. et al. “Radiofrequency treatment for middle and lower face laxity.” Arch Facial Plastic Surgery 2004; 6:370-373 have been initiated for the use of radiofrequency energy to improve facial rhytides and skin laxity. Some studies have involved the use of the ThermacoolTC System (Thermage, Inc). However, there was a small incidence of burns and residual scarring noted during some of the trials. In the ThermacoolTC System studies, results were deemed moderate with generally good satisfaction rates.
A disadvantage of the ThermacoolTC System is its high cost due to the use of complex electrodes, very high RF frequencies in the 6 MHz range, and the need for continuous impingement on the skin tissue being treated of an external cooling medium, such as spraying a freezing solution on the skin during application of the 6 MHz energy to avoid burns and possible patient harm.